MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E2516HDA
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during multiple procedures, the pens were sparking and flame issues from where the part connects the metal tip would catch on a big flame.
Additional Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7850543
• Report Number: 1717344-2018-01176
• Device Sequence Number: 11182263
• Product Code: GEI
• UDI-Device Identifier: 10884524003610
• UDI-Public: 10884524003610
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K813071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E2516HDA
• Device Catalogue Number: E2516HDA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1